Pre-Operative Window of ET to Inform RT Decisions (POWER II)

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
University of Virginia
Study ID
NCT06507618
Phase
PHASE3
Status
Recruiting
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Conditions

  • Breast Cancer Female

Eligibility Criteria

Sex
FEMALE
Age
65 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tamoxifen, Letrozole, Anastrozole, or Exemestane — DRUG
    Choice and dose of neoadjuvant endocrine therapy at the discretion of the treating medical oncologist.

Study Details

This is a Phase III, multisite exploratory study for women ≥ 65 years of age with early stage estrogen receptor positive (ER+) breast cancer. These individuals will be treated randomly assigned to one of two groups: Intervention, treated with 3 months of pre-operative endocrine therapy (pre-ET) OR Control, participants follow standard of care and proceed directly to breast cancer surgery. Both arms will be assessed for tolerance and compliance to the endocrine therapy by patient reported outcome (PRO) measures (patient surveys).

Key Dates

Start date
Jul 19, 2024
Status verified
Feb 2026
Primary completion
Jun 30, 2029
Completion
Mar 1, 2034

Study Design

Enrollment
354 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Intervention Arm
    90 days of pre-ET (endocrine therapy - tamoxifen or aromatase inhibitor) before Breast Cancer Surgery
  • No Intervention: Control Arm
    Will proceed directly to Breast Cancer Surgery

Primary Outcome Measure

Proportion of participants who omit Radiation Therapy (RT) and are non-adherent to Endocrine Therapy (ET) [ Time Frame: 24 months ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Yale UniversityNew HavenConnecticut06511
Cameron Groshek
[email protected]
8604161250
University of VirginiaCharlottesvilleVirginia22903
Meagan Miller
[email protected]
(434) 243-8101
University of Virginia Community HealthCulpeperVirginia22701
INOVA Schar CancerFairfaxVirginia22031
Shawna Willey
5714724724
Virginia Commonwealth UniversityRichmondVirginia23298
Deja Wortham
[email protected]

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Yale University· New Haven, CTUniversity of Virginia· Charlottesville, VAUniversity of Virginia Community Health· Culpeper, VAINOVA Schar Cancer· Fairfax, VAVirginia Commonwealth University· Richmond, VA

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